A Nine-Year Follow-up of Intensive Lifestyle Intervention vs Surgery to Treat Morbidly Obese Women: a Non-randomized Human Subject Research.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
研究概览
简要总结
The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.
详细描述
Behavioral/lifestyle interventions produce acceptable success in treating moderately obese subjects. However, their effectiveness on weight loss and maintenance in morbidly obese subjects remains elusive.
Twenty-nine morbidly obese females participated in this non-randomized study. Fifteen subjects were assigned to the lifestyle group and 14 underwent vertical banded gastroplasty. Subjects in the lifestyle group attended 30 behavioral modification sessions over three years, whereas the surgery group received the standard of care nutrition. Body weight, resting metabolic rate, physical activity, body composition measurements and dietary intake data were assessed at standard time points during the first 3 years post-intervention. Follow-up data on body weight and physical activity were also collected 9 years later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female sex
- •Age ≥ 18 years
- •BMI ≥ 40 kg/m2
- •Absence of mental illness as determined by evaluation by an experienced psychiatrist
- •Additional inclusion criteria for vertical banded gastroplasty were history of multiple, non-successful, previous attempts for weight loss
排除标准
- 未提供
结局指标
主要结局
The weight lost (kg) and maintained (kg) following each intervention (bariatric surgery and behavioural modification)
时间窗: 9 years
次要结局
- Physical Activity Level post bariatric surgery and behavioural modification of morbid obese patients.(9 years)
- Resting Metabolic Rate (kcal/d) post bariatric surgery and behavioral modofication in morbid obese patients.(3 years)
- Fat mass (kg) and fat free mass (kg) post bariatric surgery and behavioural modification in morbid obese patients.(3 years)
- Changes in dietary intake and eating habits post bariatric surgery and behavioural modification.(3 years)
研究者
M. Yannakoulia
Associate Professor
Harokopio University